Project manager for the Quality Systems Management workstream created to implement FDA commitments across all functional areas of AveXis.

 Supervise 5-7 exempt and hourly direct reports supporting Manufacturing floor QA support and CAPA quality system Manage quality assurance and quality oversight of manufacturing operations and QA Batch Record review Lot Disposition / Release of product lots ensuring quality and compliance of commercial API product Manage the deviation and CAPA system ensuring adequate non-conformance investigation, CAPA, and effectiveness.  Approve SOPs, batch records, investigations, equip. & process validations, process dev. reports and risk assessments Assist in the development, implementation and continuous improvement of quality systems to ensure compliance

- Project manager for AbbVie product and Contract Manufacturing Customer product changes and launches- Contract manufacturing customer liaison for Manufacturing and Finishing

Manage New Business Development quotes (~60 annually), projects and launches for 3rd party customers. Project Manager for all Drug Product NPI, development projects and process changes. Lead for strategic team to execute Voice of Customer analysis, design new process and implement Trackwise for all commercial and clinical operations to address ICH change management requirements. Project Manager for Phase I drug product development project for third party in sister division facility. Redesigned quote process including unique identifiers to improve customer communications, project tracking, financial tracking and use of SharePoint sites for internal team and third party customer use. Developed monthly financial process to ensure payment of 3rd party projects for significant dollar amt annually. Lead lean / CI initiatives, such as single point lessons, leader standard work, etc.

Supervise four non-exempt staff personnel responsible for materials coordination, training and production and department documentation in an API prodcution facility. Participated in Class A certification preparations. Co-lead successful Kaizen event to reduce errors on Safe Work Permit process. Responsible for resolving production quality issues, improving dept. policies and procedures, ensuring audit readiness, and supporting exception documentation completion. Support process transfer of new products and validation activities into production. Obtained ASQ Certified Quality Engineer certification.

Provided daily quality support in a Fermentation Recovery API manufactuing facility. Quality guidance and approval for process validation, calibration issues, exception documentation, facility upgrades and issues (including Class IV), procedural issues, MEC monitoring issues, and documentation content and adequacy API production facility. Participated in Six Sigma project as quality expert for API Process Improvement.

5th rotation on the Quality Professional Development Program at AbbottProject leader for compilation and submission of the CMC Briefing Document in preparation for a Pre-NDA meeting requiring cross-functional and third party interaction and teamwork Reviewed, commented, prepared and submitted high priority regulatory documents for FDA submissions Assist in reviewing, updating and writing Regulatory Affairs Department policies, procedures, and guidelines including acting as the RA representative on cross-functional policy teams

4th Rotation on the Quality Professional Development ProgramAssisted in supervision of QC Technicians, including scheduling, across three shifts in a liquid filling and finishing phramaceutical facility, acting as the primary supervisor for the last two months of the assignment. Facilitated communications between the QC technician staff and production and mechanic personnel to quickly resolve discrepancies/issues. Improved cGMP compliance through quality improvement project concerning reinspections

3rd Rotation on the Quality Professional Development ProgramProvided QA support for Biologics production warehouse. Coordinated and executed sprayball mapping engineering studies and resolved key quality issue discovered during the studies in a collaborative team effort . Conducted an internal audit of three areas of the Quality System.

2nd Rotation on the Qualtiy Professional Development ProgramProject leader for CRQS website redesign and launch needed as a critical communication tool. Audited the HPD Salt Lake City Medical Device Plant as a guest auditor in CRQS. Participated in the ROSS TPV Human Factors design and assessment project.

1st Rotation on the Quality Professional Development ProgramCreated training module and launched Formal Investigation training program for all investigation writers, reviewers, and approvers of the plant. Compiled and analyzed data and conducted three Plant and Division Management Reviews. Conducted and authored Formal Investigations and Exception Documentation as well as provided assistance to plant personnel. Supported multiple regulatory and third party audits.